Applied’s High Strength Firm Silicone Gel Systems 10:1 are a two part 10:1 mix of pure silicone polymers designed for use in fabricating formed soft medical devices where cohesiveness, mechanical strength and resiliency are desired. Two viscosities, 8,000 to 15,000 cps, are available. 

The product is supplied in two parts: base and crosslinker.  When combined in the ratio of ten parts by weight base to one part by weight crosslinker and cured either at room temperature for 24 hours, or accelerated by elevated temperatures, a firm, and cohesive gel results.  The cured gel is clear, colorless, and odorless, and can be formed into virtually any size and shape. 

The firmness of the gel can be controlled within a limited range by varying the crosslinker/base ratio.  Heat cure cycles can be varied to suit the user’s requirements. Important characteristics include: 

•  Cures in thick cross-sections with no by-products 
•  Clear, colorless when cured 
•  Curable to "self tack" consistency 
•  Wide range of gel firmness possible 
•  Cohesive pliable consistency conforms to complex shapes

This material was designed and tested to meet USP Class VI and ISO 10993 for long term implantation.  Additional testing is available on request.  A sample from each manufactured lot is subjected to an MEM Tissue Culture test.  

An FDA Master File reference including formulation, manufacturing methods, testing and toxicology is available.

This product was designed to be mixed in the ratio of 1.0 part by weight crosslinker to 10.0 parts by weight base. The firmness of the cured gel may be increased, i.e., a lower penetration value, by increasing the proportion of the crosslinker in the mix.  The firmness may be decreased, i.e., a higher penetration value, by decreasing the proportion of the crosslinker in the mix.  It is recommended that the crosslinker portion be limited to a range of 0.8 to 1.2 parts crosslinker to 10 parts base. Weigh out the desired quantities of base and crosslinker. Combine and mix thoroughly. Applied silicone makes a simple low cost system for vacuum mixing up to 1 gallon quantities. 

The mixture is then dispensed to fill the desired form.  As particular applications warrant and permit, the mixture may be placed under vacuum to consolidate and remove air bubbles before or after the form filling process. The mixture can be cured at room temperature or by application of heat.  Time and temperature requirements will be dependent on the particular application and should be determined by the user. 

As a guideline, full cure is achieved after about twenty-four hours at room temperature.  Full cure can also be achieved in five minutes at 150º C.  The cure temperature can be adjusted to suit particular applications. 

A material safety data sheet is supplied with the shipment.  Contact with the eye may cause temporary eye discomfort. Avoid contact with eyes.  

Accurate measuring and complete mixing are important factors in obtaining consistent results. Contamination by trace amounts of various compounds can result in an unreliable cure and/or yellowing of the gel. All metering and mixing equipment, as well as any  form into which the material is introduced, should be thoroughly cleaned. Organic rubbers often contain compounds which can interfere with the cure of the gel and should be avoided.  Any mold, form, or substrate to which this material is intended to be applied should be tested to determine that the cure or purity of the product is not affected. 

Each production lot is certified as having passed Cytotoxicity and physical testing. Other testing is available upon request.

This product is available in 8.8-pound, 44-pound, and 440-pound kits packaged in plastic bottles, pails, or epoxy lined steel drums. This material should be stored under cool and dry conditions.  Containers should be sealed. 

Suggested retest date is six months from the date of shipment.

Applied Silicone Corporation warrants that this product meets applicable descriptions and specifications for a period of six months from shipment. No other warranties, expressed or implied, are intended. This product was designed for sophisticated users. The user must carefully review literature for uses where adverse effects are reported for certain applications of silicone in medical devices. The user of this material must independently determine that any product incorporating this material is safe and effective. The user of this material must thoroughly test any application consistent with industry requirements and/or standards.  Applied Silicone Corporation disclaims any expressed or implied warranty against the infringement of any patent. Any suggestion of use by Applied Silicone should not be taken as inducement to infringe on any particular patent.